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Health Canada Authorizes SQI Diagnostics COVID-19 Prognostic Assay

NEW YORK — SQI Diagnostics said Monday it had secured Health Canada interim order authorization for its Rapid Acute Lung Injury Diagnostic, or RALI-Dx, a blood-based prognostic assay to identify which COVID-19 patients are at the highest risk of developing severe to deadly lung disease.

The Toronto-based firm said the assay detects interleukin-6 as a biomarker for severe inflammatory response from cytokine storms and the worst patient outcomes. It delivers results in under one hour, the firm said.

SQI President and CEO Andrew Morris said the test will help emergency room doctors raise survival rates among the patients with the most severe COVID-19, which continues to strain the healthcare system.

"We also hope to investigate its potential use in other severe respiratory health conditions," he said.

Physician researchers at the Toronto-based University Health Network identified IL-6 as a biomarker for severe inflammatory response, and they validated the test in a 256-patient international study, SQI said.

Shaf Keshavjee, surgeon-in-chief at UHN, said in a statement that the assay will make it easier for doctors to manage COVID-19 by helping them determine who needs hospitalization and who can be safely discharged into at-home monitoring.